FDA Inspection
Shandong Zibo Shanchuan Medical Instrument Co. Ltd.Shandong Zibo Shanchuan Medical Instrument Co. Ltd. – FDA Inspection, Oct 27, 2011
Record Details
This FDA Inspection record concerns Shandong Zibo Shanchuan Medical Instrument Co. Ltd., with an inspection on October 27, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 27, 2011
- Product Type
- Devices
View Company Profile
ID · cd68e279-6c6d-4497-b4bf-f8c268dba363
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 752315
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
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